BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT RF DR

    MDR report key: 3903647 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12763
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD SWITCHED MODE DUE TO AN OVERSENSED FAR-R WAVE EVENT. THE PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE RECOMMENDED. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380220 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR